Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - EXOGEN - Stimulator, bone growth, ultrasonic
ARTG entry for
Medical Device Included Class IIa
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
ARTG Start Date
Medical Device Class IIa
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
4721 Emperor Boulevard Suite 100
Durham, NC, 27703
United States Of America
1. EXOGEN - Stimulator, bone growth, ultrasonic
Medical device system
18154 Stimulator, bone growth, ultrasonic
The ultrasound bone healing system is indicated for the non-invasive treatment of osseous defects
conservatively or surgically treated (excluding vertebra and skull) that includes: Treatment of delayed
unions and non-unions; Accelerating the time to heal of fresh fractures; Treatment of stress fractures;
Accelerating repair following osteotomy; Accelerating repair in bone transport procedures; Accelerating
repair in distraction osteogenesis procedures; Treatment of joint fusion. The system transmits a
low-intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the
patient during the treatment. The patient administers treatment, once daily, for 20 minutes, or as
prescribed by a physician. The ultrasound bone healing system consists of one EXOGEN device, a
charger, a gel bottle, a strap and a SD Treatment Card.
No Specific Conditions included on Record
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